Public recall detail

ICU Medical Burette Set (Clave, Shut-Off)

2025-10-15

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Recall Safety notice
Quick summary

Quick summary: ICU Medical Burette Set (Clave, Shut-Off). Date: 2025-10-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: ICU Medical Burette Set (Clave, Shut-Off). Date: 2025-10-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandICU Medical, Inc.
ProductICU Medical Burette Set (Clave, Shut-Off)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-78296

Affected products

ProductBurette Set (Clave, Shut-Off)
Lot14149636
ModelB9732
Serial number14149636
DescriptionBurette Set (Clave, Shut-Off)
ProductBurette Set (Clave, Shut-Off)
Lot14176779
ModelB9733
Serial number14176779
DescriptionBurette Set (Clave, Shut-Off)

Issue

ICU Medical has identified a lot-specific issue where the burette component of the IV set is missing an internal shutoff valve intended to stop fluid flow. IV gravity burette set products that are affected will be missing the blue shutoff valve within the burette chamber.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesIcu Medical Inc. 951 Calle Amanecer, San Clemente, California, United States, 92673
Recall date2025-10-02
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-78296
Background{}
CompaniesIcu Medical Inc. 951 Calle Amanecer, San Clemente, California, United States, 92673
AudiencesHealthcare Industry
Source updated2025-10-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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